REMS helps drive the endothelin receptor antagonist to a cleaner label, as the pulmonary arterial hypertension drug's black box will be modified and liver testing requirements dropped.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.
Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.
Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.
